Global Pharmacovigilance Operations Expert

vor 7 Monaten

Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

**Your Role**:

- Responsible for maintaining an overview of existing ITM PV procedural documents and associated document change requests (DCRs)
- Interact with and be the PV delegate for the local and global SOP committees
- Coordinate and ensure PV input into relevant non-PV owned procedural documents
- Track, prioritize and coordinate/ execute the creation of new DS & PV processes
- Set-up and maintain learner roles and training curricula for PV owned processes
- Track changes in legal and regulatory requirements in the area of drug safety and pharmacovigilance (Pharmacovigilance Intelligence) and perform impact assessment
- Assist with the inspection readiness process for pharmacovigilance, audit/inspection responses from PV and vendor
- Participate in development of PV specific metrics and KPIs e.g. for training compliance
- Interact regularly with other internal departments globally and locally, such as Clinical Operations, Quality and Regulatory Affairs
- Maintain good documentation practice for all safety operation documents
- Support pharmacovigilance leadership in assigned activities and actively participate in daily pharmacovigilance activities with a “can-do, hands-on, positive attitude”

**What we are looking for**:

- University degree with a focus on the natural sciences, human medicine or pharmacy
- Professional experience in the pharmaceutical industry, with at least 4 years of experience within drug safety and pharmacovigilance
- Knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally
- Experience in safety (quality) systems and tracking metrics, compliance monitoring
- Ability to work in a team and solution-oriented
- Independent and structured way of working, attention to detail and accuracy.
- Very good knowledge of English, both written and spoken; German language skills are a plus

**What we offer**:

- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits

At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.

Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.

Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?

Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.

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